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Comparison of Three Cannulas for Hysterosalpingography

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HSG with acorn-tipped cannula
HSG with cervical vacuum cup
HSG with balloon catheter
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility focused on measuring HSG, Cannula, HSG procedure, infertility evaluation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women undergoing HSG at an academic medical center

Exclusion Criteria:

  • Contrast media allergy
  • Prior LEEP (Loop Electrosurgical Excision Procedure) or other cervical procedure
  • Contraindication to NSAID use
  • Known active pelvic infection
  • Active vaginal bleeding

Sites / Locations

  • Carolinas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Balloon Catheter

Cervical Vacuum Cup

acorn-tipped cannula

Arm Description

Outcomes

Primary Outcome Measures

pain scores

Secondary Outcome Measures

the total duration of the procedure
direct fluoroscopic time
rates of vasovagal reaction
diagnostic quality of images obtained

Full Information

First Posted
August 10, 2009
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00956774
Brief Title
Comparison of Three Cannulas for Hysterosalpingography
Official Title
Comparison of Three Cannulas for Hysterosalpingography: A Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare the three commonly used hysterosalpingography (HSG) injection devices on the basis of patient pain perception, total fluoroscopic and procedural time, and side effects in a prospective, randomized study. An important and novel secondary outcome is the comparison of the quality of images obtained with these three devices. The investigators hypothesize that the balloon catheter and cervical vacuum cup will be less painful than the acorn tipped cannula and that there will be no difference in image quality between the three groups.
Detailed Description
This study is a prospective, randomized trial of women undergoing HSG as part of their infertility evaluation. At the time of scheduling, the patient will be randomized to either the cervical vacuum cup, balloon catheter (H/S catheter set, UA Medical, Biotech America), or the acorn-tipped cannula using stratified blocked randomization. 100 subjects will be randomized to one of the three cannulas. Patients will be stratified into 4 groups representative of the four reproductive endocrinologists in order to overcome any potential interoperator bias. Four reproductive endocrinologists will perform the HSG procedures in a standardized fashion. Fluoroscopy will ensure proper location of the cannula and check for uterine filling of contrast. Digital images will document tubal filling and spilling of contrast. The patient will be rolled to right and left side to confirm free spillage of contrast in the peritoneal cavity. The last image will be taken after the balloon tip is deflated or the cannulas are removed to best evaluate the lower uterine segment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
HSG, Cannula, HSG procedure, infertility evaluation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balloon Catheter
Arm Type
Active Comparator
Arm Title
Cervical Vacuum Cup
Arm Type
Active Comparator
Arm Title
acorn-tipped cannula
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
HSG with acorn-tipped cannula
Intervention Description
Use of acorn-tipped cannula for HSG to evaluate tubal patency
Intervention Type
Procedure
Intervention Name(s)
HSG with cervical vacuum cup
Intervention Description
cup placed over cervix to create vacuum pressure.
Intervention Type
Procedure
Intervention Name(s)
HSG with balloon catheter
Intervention Description
balloon inserted via catheter into cervic for dilation.
Primary Outcome Measure Information:
Title
pain scores
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
the total duration of the procedure
Time Frame
15 minutes
Title
direct fluoroscopic time
Time Frame
15 minutes
Title
rates of vasovagal reaction
Time Frame
15 minutes
Title
diagnostic quality of images obtained
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women undergoing HSG at an academic medical center Exclusion Criteria: Contrast media allergy Prior LEEP (Loop Electrosurgical Excision Procedure) or other cervical procedure Contraindication to NSAID use Known active pelvic infection Active vaginal bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Lane, MD
Organizational Affiliation
Carolinas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of Three Cannulas for Hysterosalpingography

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